The Japan-based pharmaceutical company reported promising results in clinical trials of a stem cell therapy called Raguneprocel, which uses induced Pluripotent Stem (iPS) cells to replace lost dopamine-producing neurons. Parkinson’s disease causes the brain cells that produce dopamine to die off, which leads to a significant reduction in dopamine levels.
The study also found that the stem cell therapy improved motor function during off-times in people with advanced Parkinson’s disease. Off-times occur when symptoms become worse as an individual’s medication wears off. There are also “on times” when the medication keeps symptoms under control.Â
Sumitomo Pharma applied for authorization to manufacture and market the stem cell treatment based on results from trials conducted at Kyoto University Hospital. The therapy has received priority review designation from the Ministry of Health, Labour and Welfare, according to Sumitomo Pharma.
Parkinson’s is a progressive neurological disease that affects movement. Among the most common symptoms of the disorder are tremors (involuntary shaking), slowed movements, walking difficulties, balance problems, and cognitive impairments, such as difficulties with memory and attention.Â
Parkinson’s affects an estimated one million people in the United States and more than 10 million individuals worldwide, according to The Parkinson’s Foundation. Scientists are not sure what causes Parkinson’s disease, but they believe it could be a combination of genetic and environmental factors.
There is no cure for Parkinson’s disease, but medications are commonly prescribed to help manage symptoms temporarily. Exercise, physical, occupational, and speech therapies, as well as complementary therapies, are also used to treat the disorder, according to the foundation.Â
The current treatments for Parkinson’s can improve symptoms, but “do not slow or halt the disease progression,” the foundation said.Â
Kyoto University’s Clinical Trials
Researchers at Kyoto University conducted the clinical trials, and Sumitomo Pharma manufactured the stem cells. The trial results were published in the journal Nature in April.
The study involved seven patients aged 50 to 69 with Parkinson’s disease. Each participant received a total of either 5 million or 10 million cells implanted on both sides of the brain.Â
The iPS cells from healthy donors were developed into precursors of dopamine-producing brain cells, which are gradually destroyed in Parkinson’s disease. iPS cells are created by reverting adult cells to their juvenile state, essentially cloning without the need for an embryo. The cells can be transformed into different types of cells, making their use a vital aspect of medical research.Â
The study reported that patients were monitored for a period of two years. The primary outcome of the research focused on safety and adverse events, while secondary outcomes evaluated changes in motor symptoms and dopamine production. According to the study, the participants did not experience any significant adverse effects, and over half of them showed improvement in their motor symptoms.
While the findings suggest that transplanting iPS stem cells is a “safe and effective regenerative therapy” for patients with Parkinson’s disease, the investigators said further research is needed, which is why Sumitomo is conducting a clinical trial in the United States.Â
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